Ocular Therapeutix, Inc.

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Good morning and welcome to the Ocular Therapeutics first quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the prepared remarks, we will conduct a question and answer session. If you would like to ask a question, please press star 1 on your telephone. As a reminder, this conference call is being recorded and will be available for replay on the investor relations section of the Ocular Therapeutics website. I would now like to turn the call over to Ocular's Vice President of Investor Relations, Bill Slattery, Jr. Please go ahead, Mr. Slattery.

Good morning, everyone, and thank you for joining us today. Earlier this morning, we issued a press release and filed our quarterly report on Form 10-Q, outlining our financial results and business updates for the first quarter of 2026. During today's call, Ocular's Executive Chairman, President, and CEO, Dr. Praveen Dougal, will summarize recent business highlights before we move to our question and answer session. Joining Dr. Dougal for the Q&A portion of the call will be Donald Notman, Chief Operating Officer, Sanjay Nayak, Chief Strategy Officer, and Steve Myers, Chief Commercial Officer. We refer everyone to this morning's press release and our Form 10-Q for a comprehensive update of our first quarter 2026 financial and business results. During today's call, certain statements we will be making constitute forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially as a result of a variety of risk factors, including risks and uncertainties identified in the risk factor section of our annual report on Form 10-K and our other SEC filings. With that, I'd like to hand the call over to Dr. Praveen Dougal to review our recent updates. Praveen?

Thank you, Bill, and thank you all for joining us this morning. 2026 is off to a tremendous start for ocular therapeutics. And I want to begin by stating this clearly. SOL1 has fundamentally changed the conversation in wet AMD. In February, Xpaxly became the first novel investigational therapy to demonstrate superiority to an approved anti-VEGF agent in a phase three wet AMD trial.

That has never been done before.

the magnitude, consistency, and statistical strength of the data with a p-value of 0.0006 for our primary endpoint are giving the retina community great confidence in the robustness of the result and the probability of a potential approval as we prepare to submit our NDA-based on SOLE 1 Week 52 data, subject to ongoing formal discussions with the U.S.

FDA. But beyond the statistics, what truly excites us is the clinical significance of the data.

EXPACSLY delivered unmatched durability and sustained disease control with substantially fewer rescues. In two-thirds of the patients, just a single Expaxil-A injection maintained vision for an entire year.

That is not incremental progress. That is true differentiation. Most importantly, we're not slowing down.

Just last week, we announced the initiation of enrollment in Solex. our long-term extension trial in wet AMD designed to explore Expaxly's impact on the long-term outcomes that matter most to patients and retina specialists. Since the top-line announcement, we have continued to analyze the SOL1 results, and each successive data presentation only strengthens our conviction both at the Macula Society and most recently at the Buckel Society Annual Meeting, we presented additional 52-week analyses that further reinforce Xpaxly's unprecedented profile. For example, when we look at time to fluid volume increases, specifically thresholds of greater than 30 and 75 microns from week 8, subjects treated with Xpaxly took about five to six months longer to reach those thresholds as compared to subjects in the flibberset arm.

This is exceptional disease control. So why does this matter? Fluid is the key marker of disease activity in wet AMD.

Lower fluid accumulation reflects slower anatomic progression.

and slower anatomic progression reflects sustained disease control. And that has important implications for the long-term, which we're further evaluating in Solex.

Over time, inconsistent or pulsatile VEGF suppression, as we see in today's real-world clinical practice, may contribute to irreversible changes such as fibrosis and atrophy. What Expaxly may offer is something fundamentally different, continuous zero-order drug release and consistent disease control, which we believe could significantly alter the long-term trajectory of disease.

What we have seen to date in SOL1 with Expaxly

is not just durability in terms of dosing interval, it is also durability in terms of disease control. And that distinction will continue to be important. Furthermore, when you consider the patients who were randomized in SOL1, it becomes even clearer that what we have demonstrated with Xpaxly is simply remarkable. It's worth remembering that SOLE 1 enrolled what may be the best-seeing wet AMD population ever studied in a Phase 3 trial. As you will recall, treatment-naive subjects needed to reach 20-20 vision or gain 10 letters over 8 weeks screening and loading phase to be randomized into the trial. Since we started recruitment, we've consistently said that this population was intentionally selected specifically because they're expected to lose vision. And yet, with a single injection of Expaxly, nearly 75% of patients maintained vision at nine months, and 66% maintained vision all the way through 12 months.

That is simply profound.

We also saw a meaningfully delayed time to first rescue compared to a Fliberset. Incredibly, the rescue rate observed in the Fliberset arm at week 28 was not reached in the Xpaxil arm until six months later at week 52.

Just think about that. We're talking about a six-month delay in clinically meaningful disease change.

In wet AMD, that kind of separation has never been seen before, and it speaks directly to the durability and sustained disease control that define Xpaxly's profile. Most importantly, Xpaxly was shown to be well tolerated and so on. We have made a conscious decision to be extremely transparent with regards to safety, simply because it is so important in retinal vascular diseases. In our macular society and VBS presentations, we went so far as to provide subject-level details showing that Xpaxil-A is performing as exactly as expected and is eluding drug and bioresorbing when it should. We did not observe a single treatment-related serious ocular or systemic adverse event such as endophthalmitis or vasculitis that would be cause for concern. Instead, when you combine our superiority, durability, sustained disease control, and a reassuring safety profile, you begin to see the profile of a product that retina specialists could adopt with confidence. If approved, we believe Expatsily has the potential to become a foundational therapy in wet AMD. Based on the strength of the results, we remain on track to submit our NDA relying on SOL1 Week 52 data, subject to ongoing formal discussions with the FDA. The FDA continues to publicly communicate plans to move to a single registrational trial as the new default option for approvals. The agency's commissioner recently noted that he expects this new framework to be phased in over the next few months or so, aligning with our goal of bringing XPAC sleep to patients as soon as possible. We intend to leverage the 505 pathway, which may further allow for a shortened review timeline. Importantly, we are accelerating commercial readiness in parallel. We're building the infrastructure, engaging payers, refining our commercial strategy, and preparing for what we believe will be one of the most important launches in retina in many years.

Turning to Solar.

We completed randomization of 631 subjects in December 2025, exceeding our original 555 subject target. Because of this swift enrollment, we recently accelerated our guidance for SOL-R top-line data to the first quarter of 2027. This trial was specifically designed to complement SOL-1. Whereas SOL-1 demonstrated superiority, SOLAR evaluates non-inferiority in a de-risked population. Importantly, our 24-week screening and loading phase occurs prior to randomization, and this is designed to screen out those subjects with high fluid fluctuations, which have notoriously derailed prior non-inferiority trials. The design reflects real-world clinical practice and incorporates rescue criteria more closely aligned with how physicians treat patients. It is powered to provide additional data supporting rapid clinical adoption. Retention in SOLAR is strong, and site engagement remains tremendous. Based on the success of SOLAR-1, our confidence in SOLAR has never been higher. In addition to SOL1 and SOL-R, we are thrilled to have recently announced the initiation of enrollment in SOLEX, our open-label long-term extension study in wet AMD. Following the remarkable results from SOL1, where EXPACSLY demonstrated unmatched durability and sustained disease control, SOLEX is designed to evaluate the long-term outcomes that matter most to patients and physicians. Subjects who have completed two-year follow-up in SOL1 or SOL-R will now have an opportunity to receive Xpaxil-E for an additional three years in SOL-X, bringing the total follow-up to five years. And that is critical because wet AMD is a chronic disease. In clinical practice, we see the consequences of inconsistent disease control over time, progressive damage that can ultimately limit long-term visual outcomes, including through fibrosis and atrophy. Because all subjects in SOL-X will ultimately transition to X-Paxley, we will have a unique opportunity to observe the consequences of delaying X-Paxley treatment. Patients initially treated with Aflibraset in SOL1 and SOL-R are exposed to what we would describe as pulsatile VEGF suppression, where disease control can fluctuate over time compared to the continuous suppression we have observed with Expaxil. If that difference translates into worse long-term outcomes for patients who begin on Aflibraset and switch later, it would provide physicians with a clear rationale to initiate expaxly earlier in the disease course rather than waiting. If successful, this has implications far beyond durability. It has the potential to improve long-term vision outcomes, reduce cumulative treatment burden, and importantly, keep significantly more patients on therapy over time, which we believe could meaningfully expand the overall market. So when we think about Expaxly, we're not just thinking about a more durable therapy. We're thinking about a therapy that has the potential to be transformative over the long term. And so Lex is a critical step in potentially demonstrating that. Beyond wet AMD, our Helios 3 trial in diabetic retinopathy remains ongoing. This is a superiority study designed to support a broad label across diabetic retinal disease. It allows enrollment of patients with non-central involved DNE, reflecting the continuum of disease in clinical practice.

On June 17, in New York City, we will host an investor day, and plan to provide several important updates across our portfolio.

We will provide regulatory updates regarding our NDA submission plan in WET-AMD, detailed updates on SOLAR and SOLEX, program updates on diabetic retinopathy, and a first look at our planned commercialization strategy for Expaxly. In addition to ocular leadership, we will feature leading retinal KOLs who will share their perspective on the SOL1 data, expectations for SOLAR, the evolving wet AMD treatment landscape, and how Xpaxly could be adopted immediately if approved. We hope you all plan to join us either in person or virtually, for what we expect will be an important day outlining the future of ocular therapeutics. As of March 31st, our financial position continues to remain strong. We ended the first quarter with approximately $667 million in cash, which we expect to provide us runway into 2028. That provides us the flexibility to advance the NDA submission, complete the second year of SOL 1, continue SOL-R, SOL-X, and our Helios program, and accelerate commercial readiness. However, our cash runway does not include the full expenses we anticipate we will need to support the commercialization of X-Pax Lit. We remain focused. disciplined stewards of capital while investing strategically in what we believe is a transformational opportunity. Before we turn to Q&A, I'd like to close with a few important messages summarizing our incredible position coming out of the first quarter. Xpaxly has now demonstrated through SOLE1 the first successful superiority outcome for a novel investigative agent in wet AMD against an approved anti-VEGF. Unmatched durability with sustained disease control through one year. A safety profile that supports broad clinical adoption. In addition, with the initiation of Solex, we now have a clear path to evaluating long-term outcomes with ectapsily and its potential to fundamentally alter the trajectory of disease.

Together, we believe this combination has the potential to redefine the retina experience.

Our organization is energized, the data are compelling, execution remains exceptional, and we're advancing with urgency

toward our planned NDA submission and potential commercialization. Thank you all for your continued support. Operator, we can now take our first question.

Thank you. As a reminder at this time, if you would like to ask a question, it is the star and 1 on your touchtone telephone. If at any point you find your question has been answered, You may remove yourself from the queue by pressing star two. We'll take our first question from Fazeen Ahmed with Bank of America. Please go ahead. Your line is open.

Hi, guys. Good morning. Thanks for taking my question, and thanks for all of the clarification on timelines. Praveen, I just wanted to get a sense of how the discussions with FDA are going. So a couple of things. confidence on your view that you can apply with just SO1 to get approval, but today you provided the good news that SOLAR has enrolled at a pace that you're going to be able to have VIDA in the first quarter. So maybe can you walk us through the scenarios of what the timeline differences would be if it's decided that you can apply with SO1 versus a decision that it might be better to wait for SOLAR? Thank you.

Good morning and thank you so much for the question. Very appropriate question. Look, what we've said today and what we've said in the past is that we have ongoing formal discussions with the FDA. We couldn't be happier and I want to stress we couldn't be happier with the collaboration that we have with the FDA. We feel we're more aligned with the FDA's goals than ever. We check all the boxes and what's been demonstrated to us over and over again in our discussions and in the writings of the FDA is that there are two things that are really important with this single trial submission that I think everybody ought to note. First of all, it's a default position for the FDA. And second, the FDA views this as an elevation of the standards for a clinical trial. This is not a lowering of the bar. This is a raising of the bar. And as such, SOL1 checks all the boxes. It has a SPA. It checks all the boxes in terms of the superiority standard that was reached in terms of safety. So we're more aligned than ever. In terms of your question regarding SOLAR, look, we haven't disclosed the timelines as yet. We will when appropriate. But I remind you that we have a lot of flexibility here. in terms of SOLAR. Nothing is changing with SOLAR. We're continuing with SOLAR with the same kind of efficiency that we've always demonstrated. We're very, very happy with the engagement of the PIs and the enrollment of SOLAR, and nothing has changed. And again, I want to reiterate, we have ongoing formal discussions with the FDA. We couldn't be happier. And when the time's appropriate, we certainly will update you.

Thank you, Tuzin, for that question.

Thank you. And we'll take our next question from from Piper Sandler.

Please go ahead.

Yeah. Hi, guys. Thanks for taking my questions. And I just want to welcome back Donald. Great to have you back, Donald. So, you know, regarding the ongoing formal discussions with FDA, Praveen, can you maybe just talk about if you've had the pre-NDA meeting with the FDA? So, that's the first question. And then the second question, you know, for SOL1 in the past, you provided a snapshot on patient discontinuations and patient retention in the study. I was wondering if you could discuss these dynamics for the SOL-R study. Thank you.

Barron, good morning, and thank you. And thank you for the personal note regarding Donald. We, too, are absolutely thrilled to have Donald back, and he's an essential part of our team. And we couldn't be happier that he's back with us. In regards to the FDA meetings, again, I want to emphasize what I said earlier on, Barron, which is that we are not in the habit of disclosing the details of our FDA meetings, as is true for most sponsors. Suffice it to say that we have ongoing formal meetings that we're very, very pleased with. The collaboration with the FDA today, as has been demonstrated historically, could not be better. You recall all the modifications that we've had and have preserved our spa with this study. We also recall the modifications that we've had with the SOLAR study. All of those have been done in collaboration with the FDA, and we couldn't be happier with their support and their collaboration. And as I said earlier, when appropriate, we certainly will update you regarding the timelines. In regards to SOLAR, again, a very appropriate question. As you recall, we had a phenomenal retention rate and execution with SOL-1. That has not changed in SOL-R. We're very, very pleased with the execution. We're very, very pleased with the staff that we have in regards to patient retention. And you'll hear the details of that in our upcoming Investor Day. And I hope that all of you will be present for that in New York City on June 17th. Thank you for that question, Barron. Back to the operator.

Thank you. We'll take our next question from Tara Bancroft with TD Cowan. Please go ahead. Your line is open.

Hi. Good morning. So I'm going to stick on this theme, if I may. You know, I understand you can't give exact timing and all of that, of course, to preserve the integrity of the discussions. I was hoping maybe you could go over with us what has to be done ahead of a filing just to get a better sense of the process as you understand it and then kind of separately and related potentially timing to when we could get an update on data from SOL-X and whether this is going to be part of that review that's expected for the NDA. Thanks so much.

So, Tara, good morning and thank you for the question. Look, in regards to the FDA, again, you know, I'll repeat that we check all the boxes. We're completely aligned. And I think everything that you've seen from the FDA is in line with their intention of getting drugs to patients faster and making sure that the trials or the single trial approval process is validated. You've seen all the editorials or the editorial in New England Journal of Medicine. You've seen the criteria that was laid out by the commissioner. We check all the boxes. And in our discussions with the FDA, we're more confident than ever that we check all the boxes. In addition to that, as I said earlier, SOLAR also provides us a tremendous amount of flexibility. It's important to note again that nothing has changed with SOLAR. We're moving with SOLAR. as efficiently, as quickly, with a great deal of integrity, and nothing is going to change with that. So, we're moving with that and preserving the flexibility of whatever the FDA should desire. In regards to your question regarding Solex and the updates, we will provide more updates in our meeting in June in New York City. important to remember that Solex will provide some very, very important information in regards to the long-term effectiveness of Xpaxley. As has been mentioned, Solex will provide a lot of data. Probably one of the most important data points that Solex will provide are the crossover patients. We've said earlier that there's a great deal of evidence in our field that what causes long-term decrease in vision is atrophy and fibrosis that is caused by the pulsatile nature of our treatment. I've also mentioned several times that that's akin to having multiple concussions because after all this is neural tissue. We believe that with continuous suppression that ExPaxily will provide and by eliminating these pulsations we will have a much better long-term outcome by having less fibrosis and less atrophy. And remember, in SOLEX, patients will cross over to expaxily after receiving two years of pulsatile treatment. So we don't think those patients will ever catch up. And we believe that we'll be able to demonstrate not only the remarkable sustainability and absolutely incredible disease control that we've seen with SOL1, but we believe we'll also be able to provide substantial evidence that it will provide a better long-term outcome by having continuous suppression. And again, more details on that, Tara, in our meeting in June in New York City, which I hope you will attend. Thank you again for the question, and back to you, Operator.

Certainly.

We'll go next to Sean McCutcheon with Raymond James. Please go ahead. Sean, your line is open.

Hi, good morning, team. This is for Sean. Maybe can you speak to the optionality of adding SOAR to the safety database for the NEA submission and also the risk of unmasking SOAR if left on the table as it relates to maintaining the integrity of SOAR for global approvals? Thank you.

Yeah, good morning, and thank you again for the question, a very appropriate question. So I don't want to speak again, as I said earlier on, to the details of our conversation with the FDA. Again, suffice it to say that they're very collaborative, supportive, ongoing, and formal. What I will say is we have no intention of doing anything different to SOLAR whatsoever. The flexibility that that provides us in terms of the safety database is enormous. let alone the fact that we also have the Helios study. It's important to remember that in SOL1, everybody at week 52 has been redosed. So in SOL1 alone, there's a great deal of redosing experience. Obviously, there's a great deal of redosing experience in SOL-R as well. So again, that affords us a great deal of flexibility. On top of that, it's important to note that what we're filing is a 505B2 because both of these entities are previously FDA approved. So this drug has a lot of familiarity with the FDA. And on top of that, we have a SPA, which we believe will also add to a very efficient filing. But thank you for your question. Again, back to the operator.

Thank you. We'll go next to Lisa Walter with RBC Capital Markets. Please go ahead.

Oh, good morning. Thanks for taking your question, and congrats on the progress this quarter. A couple for me. On solar, just wondering if you can walk us through the secondary endpoints that you expect to share, and maybe could you tell us how you are measuring reduction in injection burden as well? Any color here would be helpful.

Thanks. Lisa, good morning, and thank you again. In SOLAR, we certainly will plan to share the details with you of what we will study in our meeting in June. So, wait for the details for that. In terms of injection burden, obviously we're going to be measuring the rescue rates. And again, we'll share the details with that in our meeting in June. It's important to state that I think a lot of the questions that you've asked that you're concerned about, which is very appropriate, have already really been answered in SOL1. In SOL1, we certainly see the disease control of Axpaxil. It's important to remember the patient population difference in SOLR and SOL1. In SOLE 1, patients were specifically and intentionally selected to lose vision. And that's important to understand. And I think that's something that has often been neglected. Despite that patient population, we saw an almost 75% rescue free rate at week 36. And that's quite remarkable. Perhaps more remarkable, and perhaps even more clinically relevant, is that with a single injection, despite that patient population, 56% maintained a stable CST within 30 microns. Again, I emphasize 30 microns at that time point, and that's unheard of. And remember, using the SOLAR criteria, almost 80% of patients were rescue-free in SOL1 at six months. And we feel that those 20% would perhaps be excluded in SOLAR given our very long ramp and given the fact that we have two opportunities to observe patients for fluctuations. We expect an even higher rescue-free rate in SOLAR, and we believe that Xpaxly is very well positioned to succeed in the non-inferiority SOLAR trial. Lisa, thank you again for your question. And again, a lot of those details will be addressed in the meeting in June in New York City, which I hope you will attend. Thank you again. Back to you, the operator.

Thank you. We'll go next to John Wallenbehn with Citizens. Please go ahead.

Hey, thanks for taking the question. Just wondering, Praveen, if you could talk a little bit about the feedback you received and how retina specialists plan on potentially integrating Xpaxly in the practice based on SOL1 and how that might change with the SOL-R readouts.

Good morning, and thank you for the question. Great question. And, you know, that's the... That's the discussion going on right now. My colleagues expect to have this medicine in their hands, and the discussion that's going on right now is how will they be using it and how will they be introducing it to their patients, which is a great discussion to have. I think ultimately, what I think at least, and this is just my hypothesis, is that this is the ideal drug to be every six-month fixed-dosing drug And as I've said, to have a drug that lasts, that is a fixed dosing confident every six month drug, one also has to be confident that that drug will last beyond six months, maybe nine to 10 months in case the patient gets sick, the doctor is on vacation, that kind of thing. So this is the ideal drug for that. Now how doctors will get to that fixed dosing is something that I think will be explored by the community. feel that they'll directly go to fixed dosing. I've had those discussions with my colleagues. Others feel that what they will initially do is to have a extended treatment extend that will continue to give them more and more confidence to go to that every six months fixed dosing. However they go there, I believe that that's where this drug will end up. And I think that will transform the way we treat patients with wet AMD. And in fact, I think that will align us with the rest of medicine. I've always said that treat and extend, which is what we do now, is sort of opaque. If you ask your 10 KOLs what treat and extend means, you'll get 10 different answers. And there's really no study on treat and extend in a phase three program. Treat and extend is not on any label. And it certainly is not aligned with anything we do in medicine. You don't go to your cancer doctor and say, look, I'll wait until your bladder cancer comes back before I decide what how often to see you and you certainly don't go to your cardiologist who says look I'll wait for your first heart attack before I figure out how often to treat you. So this type of fixed dosing I think is aligned with medicine. I think there's good scientific data to support it and I think that this drug is ideal for every six month dosing. The other important thing is that the adoptability I think will be very very quick and it will be seamless Nothing changes for the doctor. The workflow doesn't change. The experience doesn't change. It's a self-sealing 25-gauge needle. There's not a single new piece of equipment to buy. There's no added overhead. So I think the adoptability of this will be absolutely seamless. And I know that in talking to my colleagues, they are very enthusiastic to use this drug as soon as it's marketed. Thank you for your question. And back to the operator.

Thank you. We'll go next to Yin Chin with HC Wainwright. Please go ahead.

Thank you for taking my questions. Praveen, could you comment on whether there are any patients who have dropped out of the SO1 trial and whether any patients from SO1 who are eligible to enroll into the SOX trial have chosen to do so? So if not, what are their reasons for not enrolling into the SOX trial? Thank you.

Thank you again for your question. We haven't given the actual numbers, but suffice it to say that the retention rate is absolutely remarkable. And I'll go so far as to say that the retention rate is probably better than any other retina phase three study that we know of. This speaks to the enthusiasm not only of the patients, but also the doctors. And historically, this is borne out, right? I go back. to Lucentis and ILEA, for instance. Lucentis had a seven-year head start. ILEA came in seven years later and extended the durability by maybe a week or two and absolutely dominated the market. And you see the same kind of thing with Vibismo now. This is a real need in our community. Doctors know this. Patients know this. And seeing the data that they've seen with SOL1 makes it very, very easy for patients and for doctors to stick with this program. So there's been an overwhelming amount of enthusiasm. We haven't given you the actual numbers, but again, the retention rate of this program, I'll go so far as to say, is higher than any other Phase III program that I know, and the enthusiasm is through the roof at this point. Thank you for your question.

Back to the operator. Thank you.

Thank you. And as a reminder, if you'd like to ask a question, that is the star and one on your telephone keypad. We'll go next to Lachlan Hanbury-Brown from William Blair. Please go ahead. Your line is open.

Hi. Truman Dunkley on for Lachlan. I just wanted to ask, for the Helios 3 study, can you remind us if there's a certain proportion of patients that you will need to enroll with non-CIM DME to ensure that you have enough data to get DME in the label?

No, there is no. Again, thank you for your question. Good morning. There is really no such requirement that we have guided you to. You know, what I will say is we are very confident that we will not need to do another diabetic retinopathy study to cover all of diabetic retinal disease. And I say that because, remember, what we're doing is enrolling patients with moderate to severe non-proliferative diabetic retinopathy with non-central involving diabetic macular edema with an ordinal endpoint, which captures every facet of change with non-proliferative diabetic retinopathy. Now, the FDA historically has given approval based on the disease as opposed to the clinical trial. We absolutely believe that we will have a label that will cover all of diabetic macular edema. And you've seen evidence for this over and over again. If you go way back to Anchor and Marina, for instance, there was a restriction in visual acuity in enrollment. And you see that for Lucentis, there is no restriction whatsoever. You look at Panorama, there is no restriction for a stage of non-proliferative diabetic retinopathy in the label. And most recently, my last company, Nyveric Bio, I recall that we didn't treat a single patient with centra-involving geographic atrophy, yet if you look at the label for ISERVE, it allows for all of geographic atrophy, fovea-involving and non-foveal-involving. And in the same way, we believe that with the label, eventually, 4-X-PAX-LEA will cover all of diabetic macular edema centra-involving and non-centra-involving. And also recall that everybody with diabetic macular edema, everybody also has non-proliferative diabetic retinopathy. So all of diabetes will be covered, we believe, by the label. Again, I will add that obviously we haven't had labeling discussions with the FDA. It is far too early for that. But we firmly believe that this will be the only trial that will be necessary in the Helios programs for a broad label encompassing all of diabetic retinopathy. Thank you again for the question. Back to you, operator.

Thank you. At this time, there are no further questions in queue, so this concludes our question and answer session. I will now turn the call back to Dr. Praveen Dugal for closing remarks.

Thank you. Once again, thank you all for joining us today, and thank you for your continued support. We hope you will join us on June 17th in New York City for our upcoming Investor Day. In the meantime, if you have any questions, please reach out to Bill Slattery, our Vice President of Investor Relations. Have a great day, everyone, and thank you.

Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.